Data / Medical devices / Specimen/Tissue, Identification Orientation
Specimen/Tissue, Identification Orientation (MJI): 11 FDA-registered makers in 2 countries
11 establishments in 2 countries are registered with the FDA to make Specimen/Tissue, Identification Orientation (product code MJI, Class 1, 21 CFR 864.3010). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MJI
- Device class
- 1
- Regulation
- 864.3010
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Taiwan | 1 |
Makers of Specimen/Tissue, Identification Orientation
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Beekley Corporation | Bristol, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chemex Industrial Co., Ltd. | YUNG KANG Tainan, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cancer Diagnostics, Inc. | Durham, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evco Plastics, Div. Don Evans, Inc. | Deforest, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kite Endoscopic Innovations LLC | Concord Township, OH, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leavitt Medical, Inc. | Lehi, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanderson-Macleod, Inc. | Palmer, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterilab, Inc. | Naples, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taurus Engineering And Manufacturing, Inc. | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tanis, Inc. | Delafield, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vector Surgical, LLC | Menomonee Falls, WI, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.